Study of BAFFR-targeting CAR T-cells for B-cell Blood Cancers
This study is testing the safety and side effects of a treatment called BAFFR-targeting CAR T-cells for people with B-cell blood cancers that have returned (relapsed) or are not responding to other treatments (refractory). BAFFR-targeting CAR T-cells are made by taking your own immune cells (T-cells) and changing them in the lab to better find and attack cancer cells. You will also receive chemotherapy drugs, fludarabine and cyclophosphamide, or bendamustine, before the CAR T-cells. The study aims to find the best dose of BAFFR-targeting CAR T-cells and see how well they work. This study is open to adults aged 18 and older with specific types of B-cell non-Hodgkin lymphoma, chronic lymphocytic leukemia, or mantle cell lymphoma. The study plans to enroll 27 participants, but its current status is unclear.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 27 participants.
- What's involved
- You would undergo procedures like leukapheresis (to collect your T-cells), biopsies, and blood sample collections. You would also receive chemotherapy and the BAFFR-targeting CAR T-cells.
- Compensation
- Not stated in the trial record.
- Follow-up
- You would be monitored for side effects for up to 15 years after the BAFFR-targeting CAR T-cell infusion.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06191887
B-Cell Activating Factor Receptor (BAFFR)-Based Chimeric Antigen Receptor T-Cells With Fludarabine and Cyclophosphamide Lymphodepletion for the Treatment of Relapsed or Refractory B-cell Hematologic Malignancies
Recruiting
PHASE1Ages 18+InterventionalTreatmentMayo ClinicInvestigator-initiated
~27 participants
Updated 2026-02-13 on ClinicalTrials.gov
What's tested:Autologous BAFFR-targeting CAR T CellsBendamustineBiopsyBiospecimen CollectionBone Marrow Aspiration and BiopsyComputed Tomography
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of dose-limiting toxicities (DLT)
Measured over Up to 28 days after MC10029 (autologous B-cell activating factor receptor [BAFFR]-targeting chimeric antigen receptor [CAR] T cells product) infusion
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesFlorida1
Study leadership
- Mohamed A. Kharfan-Dabaja, M.D., M.B.A. · PRINCIPAL_INVESTIGATOR · Mayo Clinic
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
PRE-REGISTRATION: Age ≥ 18 years
PRE-REGISTRATION: Confirmed diagnosis of 1 of the following relapsed or refractory B-cell hematologic malignancies: chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), follicular lymphoma (FL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), or large B cell lymphoma (LBCL) including Richter's transformation from CLL/SLL
For CD19+ B cell malignancies; relapsed or refractory disease is defined by one of the following histopathology:
Biopsy proven SLL or flow cytometry proven CLL; relapsed or refractory disease is defined as:
Demonstration of progressive or stable disease by positron emission tomography/computed tomography (PET/CT) or computed tomography (CT) criteria according to the international workshop on chronic lymphocytic leukemia (iwCLL) 2018 criteria
Biopsy proven B-cell non-Hodgkin lymphoma (NHL) of any histopathology (including Richter Transformation of CLL); relapsed or refractory disease is defined as:
Demonstration of progressive or stable disease by PET/CT or CT criteria as the best response to the most recent chemotherapy regimen according to the revised Lugano Response Criteria for Malignant Lymphoma
PRE-REGISTRATION: Disease Specific prior lines of therapies below:
For CLL/SLL, patients must have received ≥ two prior lines of therapy, and/or ≥ 6 months of second line prior BTK inhibition (e.g. ibrutinib or other such as acalabrutinib or zanubrutinib) and must have failed to respond to venetoclax or be intolerant. Exception: Patients in stable disease (SD) or partial response (PR) with a known ibrutinib resistance mutation (BTK or phospholipase Cγ2) may be included even if on ibrutinib therapy for less than 6 months
These patients may or may not have received prior antibody directed against cluster of differentiation 20 (CD20).
For Follicular Lymphoma, patients must have received ≥ two prior lines of therapy, including an antibody directed against CD20.
NOTE: Prior cluster of differentiation 19 (CD19) directed chimeric antigen receptor T-cell therapy (CART) must have a 100-day washout period.
For Mantle Cell Lymphoma, patients must have received ≥ two prior lines of therapy, including an antibody directed against CD20, and a BTK inhibitor.
NOTE: Prior CD19 directed CART must have a 100-day washout period.
For Marginal Zone Lymphoma, patients must have received ≥ two prior lines of therapy, including an antibody directed against CD20.
NOTE: Prior CD19 directed CART must have a 100-day washout period.
For Large B cell Lymphoma, patients must have received ≥ two prior lines of therapy, including an antibody directed against CD20. Prior exposure to CD19 directed CART will be allowed at the discretion of the Principal Investigator.
NOTE: Prior failed CD19 directed CART must have a 100-day washout period
For Richter's Transformation, patients must have received ≥two prior lines of therapy, including an antibody directed against CD20.
100-day washout period starts from the date of the last prior CAR-T infusion.
PRE-REGISTRATION: Measurable disease
REGISTRATION: Positive BAFFR test
REGISTRATION: Measurable disease
REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
REGISTRATION: Hemoglobin ≥ 9.0 g/dL (unless due to documented marrow involvement with disease) obtained ≤14 days prior to registration
REGISTRATION: Absolute neutrophil count (ANC) ≥ 1500/mm\^3 (unless due to documented marrow involvement with disease) obtained ≤14 days prior to registration
REGISTRATION: Platelet count ≥100,000/mm\^3 (unless due to documented marrow involvement with disease) obtained ≤ 14 days prior to registration
REGISTRATION: Total bilirubin ≤ 1.5 x upper limits of normal (ULN) (Subjects with Gilbert's Syndrome may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN) obtained ≤ 14 days prior to registration
REGISTRATION: Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement) obtained ≤ 14 days prior to registration
REGISTRATION: Prothrombin time (PT)/international normalized ratio (INR) /activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN OR if patient is receiving anticoagulant therapy and INR or aPTT is within target range of therapy obtained ≤ 14 days prior to registration
Patients on a stable, maintenance regimen of anticoagulant therapy for ≥ 30 days prior to registration may have PT/INR measurements \> 1.5 X ULN if, in the judgment of the investigator, the patient is suitable for the study
REGISTRATION: Calculated creatinine clearance ≥45 ml/min using the Cockcroft-Gault formula obtained ≤ 14 days prior to registration
REGISTRATION: Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
REGISTRATION: Provide written informed consent understand and comply with protocol-required study procedures
REGISTARTION: Patients must have an ejection fraction (EF) of ≥ 45%
REGISTRATION: Patients must have pulse ox measurements of \> 92% on room air
REGISTRATION: Willingness to provide mandatory blood specimens for correlative research
REGISTRATION: Willing to return to enrolling institution for study follow-up
PRE-REGISTRATION: History of a seizure disorder, major cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement
PRE-REGISTRATION: Radiation therapy ≤ 14 days prior to pre-registration
PRE-REGISTRATION: Prior allogeneic hematopoietic stem cell transplant (HCT) in ≤ 6 months prior to pre-registration; patients with active graft versus host disease (GVHD) will not be eligible regardless of duration from prior allogeneic HCT
PRE-REGISTRATION: Human immunodeficiency virus (HIV) positive patients
PRE-REGISTRATION: Subjects with New York Health Association (NYHA) class III or greater heart failure
REGISTRATION: Eligible for auto-HCT based on investigator judgement
REGISTRATION: Presence of active bacterial, viral, or fungal infection that is uncontrolled, based on investigator judgment
REGISTRATION: Patients with active hepatitis B or hepatitis C infections are excluded from the study. Patients who are documented to be HIV positive or proven HIV infection from testing are ineligible for the study. Infectious disease testing (HIV-1, HIV-2, hepatitis C virus (HCV) antibody and polymerase chain reaction (PCR), hepatitis B virus (HBV) surface antigen, HBV surface antibody, HBV core antibody) performed ≤ 45 days prior to registration may be considered for subject eligibility
REGISTRATION: Previous or concurrent malignancy, except basal cell or squamous cell skin carcinoma, adequately resected and in situ carcinoma of cervix, or a previous malignancy that was completely resected and has been in remission for ≥ 5 years prior to registration
REGISTRATION: Persons of childbearing potential who are pregnant or breastfeeding
REGISTRATION: Life expectancy of \< 6 weeks
Exclusion
PRE-REGISTRATION: Prior solid organ transplantation
PRE-REGISTRATION: Unstable angina, clinically significant arrhythmia, or myocardial infarction ≤ 6 months of prior to pre-registration, or grade 3 or higher pericardial effusion at the time of pre-registration
PRE-REGISTRATION: Prior anti-BAFF-R therapies
PRE-REGISTRATION: Known contraindication to lymphodepleting (LD) chemotherapy
PRE-REGISTRATION: Use of systemic antitumor therapy or investigational agent ≤ 14 days, prior to pre-registration
PRE-REGISTRATION: Receiving any other investigational agent which would be considered as a treatment for the BAFF-R
PRE-REGISTRATION: Autologous HCT ≤ 60 days prior to pre-registration
PRE-REGISTRATION: Uncontrolled intercurrent non-cardiac illness including, but not limited to:
Previous or concurrent malignancy
Ongoing or active infection
Psychiatric illness/social situations
Dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy \* Persons of childbearing potential who are pregnant or breastfeeding
Life Expectancy of \< 6 weeks
Persons requiring systemic corticosteroids (\>10 mg prednisone or equivalent per day) and/or other immunosuppressive therapy. Patients are allowed to use topical corticosteroids
Any other conditions that would limit compliance with study requirements
What this trial measures
- Incidence of dose-limiting toxicities (DLT)Up to 28 days after MC10029 (autologous B-cell activating factor receptor [BAFFR]-targeting chimeric antigen receptor [CAR] T cells product) infusion
DLTs are defined per the protocol and assessed by the number of DLTs that occur during the DLT evaluation period and persist beyond the specified duration (relative to the time of onset, defined as within 28 days).
- Incidence and severity of treatment emergent adverse eventsUp to 15 years
Defined as adverse events (AEs) that occur or worsen in severity on or after MC10029 product infusion.